Bird Droppings, Missing Test Data, Fraudulent Records: USFDA Flags Major Deficiencies at Dabur Unit

New Delhi: Dabur India has come under intense regulatory scrutiny after investigators from the U.S. Food and Drug Administration (USFDA) documented a series of significant quality, data integrity and manufacturing control deficiencies at the company's over-the-counter (OTC) drug manufacturing facility in Dadra and Nagar Haveli.

According to a Form FDA 483 issued following an inspection conducted between January 12 and January 16, 2026, FDA investigators cited seven major observations covering laboratory practices, quality oversight, cleaning validation, production records, facility maintenance, equipment controls, process validation and stability testing.

The FDA's most serious findings centered on the facility's microbiology laboratory operations, where investigators reported extensive deficiencies in data integrity, documentation and analytical controls.

Investigators noted that more than five years of finished-product microbiological testing records reviewed during the inspection showed that 100% of results had been reported as “less than 10” colony-forming units, effectively indicating zero microbial growth. However, during plate-reading activities observed on January 12, 2026, FDA investigators reportedly identified visible microbial colonies on multiple plates, including two plates that were “too numerous to count” (TNTC), findings that were inconsistent with the historical laboratory records.

The agency further observed repetitive numerical patterns in duplicate microbial testing data that appeared unlikely to represent actual analytical results, raising concerns about the authenticity and reliability of laboratory records.

FDA investigators also reported that numerous microbiological testing plates referenced in analytical notebooks could not be located during the inspection. The firm allegedly lacked documentation explaining the disposal or whereabouts of these plates.

Compounding the issue, the company had not established sample receipt logs for finished-product and microbiological samples, preventing verification of chain of custody and testing timelines.

The agency further found that microbial colony counting was performed by a single analyst without independent verification, while growth-promotion testing for microbiological media was conducted only upon receipt rather than for every prepared batch of media used during testing.

According to the FDA, the quality control unit failed to identify the absence of microbiological out-of-specification results over a five-year period and did not detect broader analytical and data-integrity concerns.

One of the most serious observations involved manufacturing documentation.

The FDA stated that on January 15, 2026, the firm created equipment usage records that investigators described as fraudulent and designed to conceal multi-product manufacturing operations. The newly generated documentation reportedly omitted references to several U.S.-marketed OTC products that had been recorded in the original equipment logbooks.

Review of original records indicated that equipment previously represented as dedicated to a single product had in fact been used for manufacturing multiple OTC products. Investigators concluded that the preparation of revised records compromised the integrity and completeness of manufacturing documentation and violated principles of contemporaneous record-keeping.

The agency also noted that the company lacked a formal risk assessment addressing the manufacture of multiple products on the same production line.

FDA investigators reported additional deficiencies within the finished-product inspection program. Inspection results were initially recorded on uncontrolled loose sheets of paper before being transferred into official notebooks.

The agency further alleged that records overstated the number of product units examined and that the company failed to initiate deviation investigations or non-conformance reports after identifying critical defects, including empty units and coding errors in finished products.

The FDA also criticized the company's cleaning validation program for non-dedicated manufacturing equipment used across multiple products.

Investigators found that cleaning verification relied primarily on visual inspection rather than scientifically justified analytical methods capable of detecting residual contamination below visible levels.

The validation program reportedly lacked established maximum allowable carryover limits, quantitative residue limits and microbiological acceptance criteria. Sampling strategies were considered inadequate because they did not include direct surface sampling from difficult-to-clean equipment areas and product-contact surfaces.

The agency further highlighted that the manufacturing line handled multiple OTC products with varying formulations, creating heightened risks of cross-contamination that were not adequately addressed through cleaning validation.

The FDA stated that one production line represented as dedicated exclusively to a specific product was actually used for manufacturing multiple products without any cleaning validation.

According to investigators, this alleged misrepresentation, combined with the absence of cleaning validation studies, created potential product carryover concerns affecting more than 100 batches of OTC pharmaceutical products manufactured during the previous three years and still within expiry.

The agency also criticized the firm's broader validation strategy, noting that cleaning validation data generated from a single production line and product had been extrapolated to multiple non-dedicated lines manufacturing different products without adequate scientific justification.

FDA investigators reviewed manufacturing and analytical records across multiple batches and products and identified numerous documentation failures.

Among the deficiencies cited were discrepancies between analytical data recorded in batch manufacturing records, certificates of analysis (COAs) and laboratory notebooks for tests such as residue on ignition, melting range, pH and viscosity.

The agency also found that no standard testing procedures, analytical worksheets or test sheets were available to support several critical analytical results reported in COAs. Investigators stated that the company had released numerous batches over the past three years without maintaining complete analytical data records.

Additional concerns included:

• Interchanged assay values between third-party and company-issued certificates of analysis.
• Missing equipment logbook entries for testing instruments.
• Failure to record critical process parameters in batch manufacturing records.
• Incorrect documentation of active pharmaceutical ingredient quantities.
• Missing equipment identification details.
• Incomplete signatures and review approvals for cleaning, sanitation and in-process testing activities before batch release.

The FDA also cited the company for failing to conduct Annual Product Quality Reviews (APQRs) for the majority of products manufactured at its facilities.

Although APQRs were available for certain products, investigators noted that numerous OTC drug products lacked annual quality reviews despite the company's own standard operating procedures requiring such evaluations for all marketed products.

The inspection further identified facility sanitation deficiencies.

Investigators observed a live bird and bird droppings in the raw-material warehouse approximately 30 feet from packaging materials. They also reported the presence of an unidentified black substance covering more than 25% of ceiling surfaces in both raw-material and finished-product warehouses.

In addition, a gap of approximately one inch was observed in a warehouse dock door, potentially allowing pest ingress.

The FDA reported that hoses connected to points of use within manufacturing areas contained stagnant water, creating potential microbiological contamination risks.

These hoses were reportedly used during cleaning operations for tanks involved in drug manufacturing, raising concerns about the quality of cleaning processes and potential contamination of pharmaceutical equipment.

The inspection concluded with observations regarding inadequate production and process controls.

The FDA stated that the company had not completed required process validation studies for certain products. Investigators also found weaknesses in the stability testing program, including the absence of a complete inventory of stability samples under test and inadequate procedures for reviewing stability data generated by external laboratories.

While a Form FDA 483 represents inspectional observations rather than a final regulatory determination, the breadth of deficiencies documented at the facility suggests significant concerns regarding data integrity, quality oversight, documentation practices and manufacturing controls.

The observations are particularly notable because several findings relate to fundamental current Good Manufacturing Practice (cGMP) requirements, including laboratory data integrity, record authenticity, cleaning validation and quality unit oversight. Regulatory experts note that issues involving potential data manipulation and creation of inaccurate records typically receive heightened scrutiny from health authorities due to their direct impact on product quality assurance and patient safety.

Dabur India is expected to submit a detailed corrective and preventive action (CAPA) response to the FDA addressing each observation and outlining measures to restore compliance with U.S. regulatory requirements.